C&Q Engineer – Dublin

Descriere Job:

Summary:
Our client one of Europe's largest manufacturers of OSD & API Pharmaceuticals now require a C&Q Engineer for its site in South Dublin, responsible for commissioning and qualification of biopharmaceutical process equipment packages (upstream/downstream).

Reporting to:
S (he) will report to the Engineering Lead.
Responsibilities
• Coordinate and supervise third party vendors during SAT execution.
• System P&ID walkdown with construction prior to handover. Categorisation of punchlist items & tracking to completion. Acceptance of system at mechanical completion (M/C).
• Generation, review and approval of C&Q protocols.
• Execution of the system commissioning protocols, Installation & Operation Qualification protocols.
• Pre-start safety checks, lock out & tag out & ensuring timely loop checking post handover.
• Attend daily communication meetings with area lead and report progress.
• Generate method statements, risk assessments & permit preparation for responsible areas from M/C to handover to site operations.
• Ensure non-conformances & deviations are minimized and closed out with Engineering and QA Validation in a timely fashion.
• Ensuring that punch list items are documented, tracked, expedited and resolved prior to handover.
• Handover to Tech Services and Operations in a fully functioning GMP state for execution of Demo Batches
• Ensure all company and site engineering policies and procedures are adhered to.
• Operate according to SOPs developed for verification, validation, validated manufacturing operations and cGMP compliance.
• Work to implement a culture of Right-First Time & Zero Defects